Stability Expert

Job description

Janssen Supply Chain (JSC) is a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provide access to and affordability of medicines through innovation and strong collaboration with their R&D and commercial partners to deliver life changing solutions for patients in need.

Global Stability Operations is a department within the Janssen supply chain, responsible for the stability management of pharmaceutical products and active pharmaceutical ingredients manufactured in the different manufacturing sites worldwide and for the site-to-site analytical method transfers within Janssen Supply chain (JSC).

To strengthen our team, we are looking for a (temporary) Stability Integrator / Stability Owner who will manage an own portfolio of products.

Responsibilities
This position is responsible for Stability Management of Drug Substance/ Drug Products and site-to-site Analytical Method Transfers within JSC. The main roles and responsibilities of this position will be:

·  Stability and Analytical Transfer Management of a portfolio of products
·  First point of contact for stability and transfer related issues and lead for escalating stability OOTs/OOSs
·  Trending and profiling of product behaviour
·  Supporting and coordinating investigations
·  Scientific and Quality evaluation of generated results
·  Draw up conclusions on shelf life/ retest period, storage conditions and instructions, shipment excursions and method transfer status
·  Assuring resources are planned (e.g., stability storage conditions and space, equipment, reagents, people, skills, etc.)
·  Coordinating Safety Health & Environmental (SHE) assessments of new chemicals and reagents for the stability testing labs
·  Readiness of the stability group for New Product Introductions (NPI)
Additionally this position will:

·  Be an advisor for stability related questions and issues.
·  Participate in projects as stability expert
·  Follow-up / handle regulatory questions
·  Manage changes of shelf life/retest period, storage instructions and method transfer
·  Prepare for inspections and act as spokesperson if applicable
·  Build up scientific expertise and background knowledge on product behaviour
·  Accountable to manage and assure quality & compliance
·  Ensure compliance with all relevant regulations, guidance, compendial requirements for stability studies, analytical methods and specifications.

Desired profile

·  Degree: Master in pharmacy, analytical chemistry, biochemistry, industrial engineer or equivalent;
·  1-3 years of experience with analytics or stability (Formulations and bulk drugs) in a GMP environment; knowledge of stability guidelines are an advantage;
·  We expect:
·  Quality mind-set;
·  Proactive attitude and initiative taking;
·  Analytical thinking skills;
·  Problem solving skills, creative mindset;
·  Decision making skills;
·  Able to work independently, As well as good team player;
·  Project management skills
·  Negotiation, communication and presentation skills across all levels of the organization
·  Networking skills
·  Accuracy and commitment to timeframes;
·  Able and willing to work in an international environment;
·  Able to write and speak English fluently.

What's in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.